Purpose

To study the effect of daily disposable contact lens (DDCL) refitting in monthly contact lens (CL) wearers suffering from contact lens discomfort (CLD), and to assess if there is a placebo effect associated with this CLD intervention.

Methods

Symptomatic CL wearers, according to the Contact Lens Dry Eye Questionnaire 8 (CLDEQ-8 ≥ 12 points), were divided into two groups. The study group was provided with DDCLs (delefilcon A) and the control group with a masked pair of their habitual monthly CLs (placebo effect) and were assessed after one month. Then, the control group was provided with the same DDCLs and evaluated one month later. The symptoms were recorded with the CLDEQ-8 and global rating of change scale (GRCS). Non-invasive tear break-up time (NITBUT), conjunctival hyperaemia, fluorescein staining, and lid wiper epitheliopathy (LWE) were evaluated. Changes between visits, groups, and the effect of each intervention were analysed.

Results

Thirty-one participants (mean age: 23.2 ± 5.3 years) were recruited. The study group (n = 14) showed an improvement of -39.6 ± 25.8 % (p < 0.001) in CLDEQ-8 and 31.3 ± 14.6 points in GRCS (p < 0.001) after one month of DDCL use, while no changes in clinical tests were found. In the control group (n = 17), symptoms improved significantly after wearing the masked monthly CL (CLDEQ-8: -26.1 ± 31.0 %, p = 0.03; GRCS: 14.9 ± 17.0, p = 0.002), however a worsening in bulbar (26.5 ± 40.0 %; p = 0.02) and limbal hyperaemia (21.6 ± 34.7 %, p = 0.02) and an improvement of -19.1 ± 37.0 % (p = 0.049) in LWE was found. When the control group was fitted with the DDCL, improvements in GRCS (20.5 ± 25.5, p = 0.02), NITBUT (37.9 ± 42.3 %, p = 0.002), and conjunctival staining (-47.1 ± 59.9 %, p = 0.005) were noted.

Conclusions

Refitting symptomatic monthly CL wearers with Delefilcon A DDCL is effective in reducing symptoms related to CLD. However, clinicians and researchers must be aware of the existence of a placebo effect when assessing the effectiveness of any CL refitting.

中文翻译：

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隐形眼镜不适管理中是否存在安慰剂效应？

目的

研究每日一次性隐形眼镜 (DDCL) 改装对患有隐形眼镜不适 (CLD) 的月度隐形眼镜 (CL) 佩戴者的影响，并评估是否存在与此 CLD 干预相关的安慰剂效应。

方法

根据隐形眼镜干眼问卷 8（CLDEQ-8 ≥ 12 分），有症状的 CL 佩戴者分为两组。研究组提供 DDCLs (delefilcon A)，对照组提供一对他们习惯性的每月 CLs（安慰剂效应），并在一个月后进行评估。然后，为对照组提供相同的 DDCL，并在 1 个月后进行评估。症状用 CLDEQ-8 和全球变化评定量表 (GRCS) 记录。评估了非侵入性泪液破裂时间 (NITBUT)、结膜充血、荧光素染色和盖子擦拭器上皮病变 (LWE)。分析了访问之间、组之间的变化以及每种干预的效果。

结果

招募了 31 名参与者（平均年龄：23​​.2 ± 5.3 岁）。研究组（n = 14）显示，使用 DDCL 一个月后，CLDEQ-8 的改善为 -39.6 ± 25.8 %（p < 0.001），GRCS 的改善为 31.3 ± 14.6 分（p < 0.001），而临床表现没有变化测试被发现。在对照组 (n = 17) 中，佩戴面罩每月 CL 后症状显着改善 (CLDEQ-8: -26.1 ± 31.0 %, p = 0.03; GRCS: 14.9 ± 17.0, p = 0.002)，但延髓恶化(26.5 ± 40.0 %; p = 0.02) 和角膜缘充血 (21.6 ± 34.7 %, p = 0.02) 和 LWE 的改善 -19.1 ± 37.0 % (p = 0.049)。当对照组安装 DDCL 时，GRCS (20.5 ± 25.5, p = 0.02)、NITBUT (37.9 ± 42.3 %, p = 0.002) 和结膜染色 (-47.1 ± 59.9 %, p = 0.005) 的改善为著名的。

结论

使用 Delefilcon A DDCL 改装有症状的每月 CL 佩戴者可有效减轻与 CLD 相关的症状。然而，临床医生和研究人员在评估任何 CL 改装的有效性时必须意识到安慰剂效应的存在。